Adaptive Biotechnologies Highlights Role of Highly Sensitive MRD Testing in New International Myeloma Society Definition of Cure

SEATTLE, Sept. 25, 2026 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today highlighted the new consensus definition of cure for multiple myeloma, presented at the International Myeloma Society (IMS) 23rd Annual Meeting in Glasgow, Scotland, on behalf of IMS and the International Myeloma Working Group (IMWG).

Long considered an incurable disease, multiple myeloma is entering a new phase in which some patients are remaining free of detectable disease for years after treatment ends. Significant advances in both myeloma therapeutic strategies and disease monitoring technologies are giving clinicians more effective ways to drive deep responses and more sensitive ways to measure them. As more patients achieve these outcomes, a clear standard for determining when a long-term response may be considered a cure is necessary. The new consensus definition establishes that standard and places sustained measurable residual disease (MRD) negativity at the center of determining whether a deep response has endured over time.

Under the consensus definition reached by global myeloma experts, a patient with newly diagnosed or relapsed disease may be considered cured after five years in complete remission without any myeloma treatment. During that period, the definition requires:

• At least four negative MRD assessments, including one at the five-year mark, with no positive result in between.
• MRD tests must use next-generation sequencing or next-generation flow at a sensitivity of 10⁻⁶, or one myeloma cell among one million cells.
• Advanced imaging, using PET/CT or diffusion-weighted whole-body MRI, must show no disease at the start and end of the period, with no positive scan in between if additional scans are performed.
  

These criteria illustrate that advanced disease assessment methodologies, including clonoSEQ^®, will play a central role in determining which patients meet the definition of cure.

“In the world of treating multiple myeloma, we have now reached a point where we can actually cure patients. Part of that cure definition is that the patient has no measurable disease in their bone marrow,” said Dr. Jeffrey Wolf, clinical professor, Department of Medicine, University of California, San Francisco.  “The ideal way of measuring that is to use the clonoSEQ Assay, which has been proven over many years to be the most reproducible way of defining residual disease in these patients.”

Establishing this consensus definition is the beginning of a new era for patients; significant ongoing research will be required to continue to expand the fraction who are cured and to better understand the probability of cure in specific patient subpopulations. 

“Patients are excited to hear the cure conversation gain momentum but want to balance the hope with their lived reality,” said Jenny Ahlstrom, myeloma patient and CEO and founder, HealthTree Foundation. “Given that all myeloma is not the same, learning who can and will be cured will be one of the most important discoveries in the near future.”

“The consensus definition of cure in myeloma marks a defining moment for the patient community and a landmark achievement for the field. Together with last week’s NCCN Guidelines^® update, this development clearly affirms that highly sensitive MRD assessment should be systematically integrated into routine myeloma care,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “As the first and only FDA-cleared next-generation sequencing MRD test, clonoSEQ is uniquely positioned to support the level of rigor the cure definition requires, giving clinicians a precise way to measure deep responses over time and offering patients clearer insight into the outcome of their treatment.”

About clonoSEQ
clonoSEQ^® is the first and only FDA-cleared in vitro diagnostic (IVD) test for detecting and tracking minimal (or measurable) residual disease (MRD) in patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) using bone marrow, and in patients with chronic lymphocytic leukemia (CLL) using blood or bone marrow. clonoSEQ is also available in diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and other lymphoid cancers and specimen types as a CLIA-validated laboratory-developed test (LDT). clonoSEQ is covered by Medicare for MM, CLL, ALL, DLBCL and MCL.

clonoSEQ identifies and quantifies DNA sequences in malignant cells—detecting one cancer cell in one million healthy cells—to help clinicians and researchers assess and monitor MRD with precision over time. It delivers standardized, sensitive results that inform treatment decisions, predict outcomes, and detect relapses earlier. clonoSEQ has been extensively studied in more than 300 peer-reviewed publications.

clonoSEQ is CE-marked under the EU In Vitro Diagnostic Regulation (IVDR). For intended use details in the EU, see the instructions for use, available on request.

To review the FDA-cleared uses of clonoSEQ, visit clonoSEQ.com/technical-summary.

About Adaptive Biotechnologies
Adaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision, and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient.

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